DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 12-15 and 20-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Elected claims 16-19 and 30-33 are pending. Election was made without traverse in the reply filed on January 9, 2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The examiner suggests reference to the generation of a library from simulated electrical heart activity in the evaluation of arrhythmias.
Claim Objections
Claims 16 and 30 are objected to because of the following informalities: the examiner suggests inserting a comma between consecutive occurrences of the word “library” for readability purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-19, 31 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 17 and 31, the examiner cannot find in the original disclosure any reference to automatic positioning of an ablation device.
Regarding claims 18 and 32, while the applicant has support for the use of a radiation therapy device in the original disclosure (see pars. 0002 of the present application, the parent application, and the ‘557 application incorporated by reference), the examiner cannot find support for the use of a stereotactic body radiation therapy device.
Regarding claim 19, the examiner cannot find in the original disclosure any reference to the one or more computing systems providing instructions to position an ablation device, and activate energy of the ablation device. It appears that the applicant merely suggests that the arrhythmias may be treated, but does not state that the device itself provides instructions to position an ablation device and activate energy of the ablation device.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 30-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 30, it is unclear if the recitations associated with the generation of the library (i.e., the accessing, stimulating, generating and adding steps following the colon on line 5) are to be considered a part of the method, or if the steps merely indicate the type of source data to be accessed. If it was the applicant’s intent to include the accessing, stimulating, generating and adding steps as a part of the claimed method, then it is suggested that the applicant positively recite the step of generating a library in accordance with these steps, prior to the step of accessing the library.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,974,853. Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention’s claims are merely broader in scope than the patented claims. Note in particular the interpretation made in the rejection of claim 30 above under §112, where none of the steps involved in generating the library have been positively recited as a part of the method. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Regarding claims 31 and 33, indicating the source location of an arrhythmia to an ablation device for positioning purposes would have been obvious to those of ordinary skill in the art since the source location is the location that would require ablative energy in order to prevent the arrhythmia from reoccurring.
The use of an ablation device that is a stereotactic body radiation therapy device (claim 32) would have been considered a matter of obvious design. The applicant discloses that many different technologies may be used to provide therapy (see par. 0002). One would expect any known ablation apparatus, including known stereotactic body radiation devices, capable of accurately ablating targeted cardiac tissue to have been successful.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 30-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) the mentally performable steps of identifying patient cycles of a patient cardiogram that are similar to each other, and retrieving from the library, library cycles that are similar to the patient cycles. Such steps involve observation, analysis and opinion, and are reasonably mentally performable within the human mind.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), as the display and any memory associated with the step of accessing information, functions in its usual capacity; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, but only display of information – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), but generic computer-readable media and displays; there is no transformation or reduction of a particular article to a different state or thing, but only data manipulation, as discussed in MPEP 2106.05(c); and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of cardiac signal processing and display, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of accessing a library of library cycles is considered insignificant data gathering that would be required in the performance of the abstract idea. Note the comments made above in the rejection of claim 30 under §112 regarding interpretation of the accessing, simulating, generating and adding recitations (the adding to a library step can further be considered mentally performable as it involves memorization). As stated in MPEP 2106.05(g) and MPEP 2106.05(h), the Courts have found the selection of a particular source of the data, or how the data was originally generated, to be insignificant and/or a field of use limitation. It is not significant, for example, how the data was obtained, such as via a look-up table, measured data, etc., as the data would be indistinguishable between the various sources. The step of displaying is considered insignificant data outputting as all practices of the abstract idea would require such data outputting in order to present the information in human perceivable form.
The step of accessing data from a library and displaying the outcome of a comparison analysis is also considered WURC in the art, whether considered individually or in combination. All practices of the abstract idea would require a data source and a display to output the results of the comparison. The applicant does not disclose any specific display or non-generic data storage configuration. Displays and memories for containing data are WURC in the art as discussed by the applicant in par. 0035.
Regarding claims 31-33, said claims fail to provide any practical application to the abstract idea as there is no recitation of any affirmative therapy. The claims merely reference ablation, but do not require ablation responsive to any determined condition discovered by the abstract idea. Generic stereotactic radiation devices are further WURC in the art, as is their presence in systems for determining arrhythmia source locations. As disclosed, the applicant states that many different technologies may be used to target the source of the heart disorder (par. 0002). Such devices are considered insignificant extra-solution activity.
It should be noted that in claim 16, the acts of simulating electrical activity of a heart having a particular source configuration and generating a simulated cardiogram based on the simulated electrical activity were considered not to be reasonably performed within the human mind (see Example 38 of the 2019 Subject Matter Eligibility Examples). These additional elements integrate the abstract idea of identifying patient cycles of a patient cardiogram that are similar to each other and retrieving from a library, cycles that are similar to the patient cycles, into a practical application. These elements permit large numbers of simulations to be generated based on known source configurations of a heart, which can then be compared to a patient’s cardiogram in order to identify source locations of arrhythmias for subsequent treatment.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16, 30 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krummen et al. (Krummen: Pub. No. 2017/0178403).
Regarding claim 16, Krummen discloses one or more computing systems 110 for displaying cardiac information on a driving force of an arrhythmia to assist in evaluation a heart disorder of a patient (abstract), the one or more computing systems comprising: one or more computer-readable storage mediums 116, 120 that store computer-executable instructions for controlling the one or more computing systems to: access source configurations of a heart (configurations stored in model library), each source configuration specifying a source location of an arrhythmia (model library includes information on source locations, par. 0074); for each of a plurality of the source configurations, simulate electrical activity of a heart having that source configuration (model library includes specific simulated models representing VF/AF mechanisms incorporating various source configurations such as rotors and focal points, pars. 0049, 0074); generate a simulated cardiogram based on the simulated electrical activity (e.g., VCG simulated models); and add to a library, library cycles in association with the source location of that source configuration (VCG models representing various source locations stored in a library 192, pars. 0043-0045, 0060, 0079), the library cycles derived from that simulated cardiogram (generated/simulated models stored in library); identify patient cycles of a patient cardiogram that are similar to each other (multiple patient VF cycles of a patient’s cardiogram compared to determine cycles with highest correlation to stored VF cycles of stored cardiograms, par. 0080); retrieve from the library, library cycles that are similar to the patient cycles (comparison of patient derived data to models stored in library, pars. 0077, 0079); and display a representation of a heart and source location indicators derived from the source locations associated with the retrieved library cycles (pars. 0071, 0082, etc.); and one or more processors 190 for controlling the one or more computing systems to execute one or more of the computer-executable instructions.
Regarding claim 30, note the comments made above in the rejection of this claim under §112. Krummen discloses a method performed by one or more computing systems 190 for displaying cardiac information on a driving force of an arrhythmia to assist in evaluation a heart disorder of a patient (abstract), the method comprising: accessing a library of library cycles that are each associated with a source location of an arrhythmia (model library includes information on source locations, par. 0074), the library having been generated by: accessing source configurations of a heart, each source configuration specifying a source location of an arrhythmia; for each of a plurality of the source configurations, simulating electrical activity of a heart having that source configuration (model library includes specific simulated models representing VF/AF mechanisms incorporating various source configurations such as rotors and focal points, pars. 0049, 0074); generating a simulated cardiogram based on the simulated electrical activity (e.g., VCG simulated models); and adding to a library, library cycles in association with the source location of that source configuration, the library cycles derived from that simulated cardiogram (VCG models representing various source locations stored in a library 192, pars. 0043-0045, 0060, 0079); identifying patient cycles of a patient cardiogram that are similar to each other (multiple patient VF cycles of a patient’s cardiogram compared to determine cycles with highest correlation to stored VF cycles of stored cardiograms, par. 0080); retrieving from the library, library cycles that are similar to the patient cycles (comparison of patient derived data to models stored in library, pars. 0077, 0079); and display a representation of a heart and source location indicators derived from the source locations associated with the retrieved library cycles (pars. 0071, 0082, etc.).
Regarding claim 33, Krummen discloses that ablative energy may be applied to the source location (par. 0003). Such a procedure would inherently require positioning the ablation device and activating it to perform the ablation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17-19, 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krummen et al. ‘403.
Regarding claims 17 and 31, note the comments above. While Krummen does not explicitly disclose a computing system that comprises instructions to provide for automatic positioning of an ablation device to target the source location, such a feature would have been considered obvious to those of ordinary skill in the art. Krummen discloses that the source location may be identified for ablation and/or external radiation therapy (pars. 0003, 0057, 0076), and that a steerable ablation catheter may be employed (par. 0061). Given the goal of providing therapy to target the source of the arrhythmia, the provision of an instruction or indication to automatically instruct positioning of the steerable ablation device to the target location would have been obvious.
Regarding claims 18 and 32, while Krummen discloses that one may use a variety of devices to ablate the targeted tissue, including a body radiation therapy device (par. 0003), the device is not described as a stereotactic device. Official Notice is taken that stereotactic radiation devices are well-known in the art due to their ability to apply treatment precisely to targeted areas. Given the lack of criticality by the applicant and the known use of such devices to ablate tissue, those of ordinary skill in the art would have considered such a device to be an obvious matter of design dependent upon the particular situation at hand.
Regarding claim 19, while Krummen discloses that ablation devices may be positioned to target the source of the detected arrhythmia, there is no explicit reference to providing an instruction to activate energy of the ablation device to perform an ablation. Such an instruction, however, would have been considered blatantly obvious to any artisan of ordinary skill in the art. Clearly the intent of Krummen is to apply ablative energy to the source location. Providing a literal instruction to do so would merely be confirming the intent of the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mansi ‘744 discloses a deep learning technique for identifying target ablation locations. Haeusser ‘951 discloses a system using simulated body surface electrograms of known origin to train the model.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached on the 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
March 6, 2026